新型人造心脏瓣膜全热解碳双叶瓣的植入研究
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摘要
新型人造心脏瓣膜——全热解碳双叶瓣是与上海九凌冶炼公司合作，于1995年初研制的第三代人造心脏瓣膜。它有别与St．Jude瓣和CarboMedics瓣等目前临床上常用的进口双叶瓣，它的瓣架和瓣阀均由热解碳一种材料制成的(无基体)，而后者是石墨基体外热解碳涂层的。先前的体外测试结果表明，该新型人造瓣膜经久耐磨，有效瓣口面积较大，人造瓣的跨瓣压差小，具有良好的流体动力学特性。本研究即按照GB12279-90和ISO5840-96(E)人造心脏瓣膜测试要求，对新型全热解碳双叶瓣进行动物植入研究和临床植入研究，为临床应用提供科学依据。
一．动物植入研究
材料与方法：健康羊15只，气管插管、全身麻醉，颈内静脉插Swan-Ganz导管。采用标准的体外循环方法行二尖瓣置换手术，植入21mm新型人造瓣。术后肝素抗凝3个月。选
Pi以d
一
择与人造瓣匹配较好的6只羊，术中在体外循环结柬后，直视下用双导管法直接测定左房
压（Pod、左室压OLV），计算跨瓣压差；同时用热稀释法测定该时的心排量（CO）等血流动力
学参数。
长期存活的羊分批于术后1周、12周、30个月处死。所有动物都作尸检，检查人造
瓣膜有无坏损，房、室面人造瓣膜上有无血栓形成，解剖心、肺、肝、脾、肾、大脑等脏
器有无栓塞现象。2只羊在术后30个月行心脏超声检查，观察人造瓣膜在体内的状况，
有无瓣周漏及血栓形成等，并测定羊的心排量和跨瓣压差等。再次全麻、开胸，直视下用
双导管法直接测定左房压p、左室压oLV），得出跨瓣压差，同时测定该时的心排量（C）
等（方法和仪器同前）。然后用多巴酚丁胺负荷试验模拟动物的运动状况，在模拟运动状
况 F测定瓣膜的血流动力学参数。多巴酚厂胺剂量 stwin—I0twin～
20uglkg／ffiin，每隔 15分钟增加剂量，分别测定不同剂量多巴酚丁胺导致血压、心率、心
排量等变化下的P。、P。、等参数，评价人造瓣膜在运动状况下的血流动力学性能。
结果：5只羊术后24h内死亡，5只2448h死亡，另5只长期存活，生长良好，体重增
加。手术死亡均与人造瓣膜本身无关，主要手术死亡原因是羊的二尖瓣环与人造瓣膜大小
不匹配引起瓣环撕裂、急性心衰而死亡。尸检见人造瓣无坏损，机械性能良好；心腔内无
血栓形成，肺、肝、脾、肾、脑等脏器的大体检查和病理切片均无栓塞的证据：心内膜光
滑，无人造瓣膜心内膜炎的征象。术中导管测得的跨瓣压差为5．2土1．7mmHg，术后30个
月导管测得静息下的跨溶压差为6．l土0．3mlnHg。模拟运动状况下，随多巴酚丁胺剂量的
增大，心排量（CO）明显增加，而跨瓣压差随CO的明显增加仅轻度增大。心超测定的跨瓣
压差为 6．8土0．4mlnHg，与用导管法直接测得的跨瓣压差非常接近。实验表明该瓣膜的跨
瓣压差较小，血流动力学性能良好。
二．屹床桓入扭究
2
P｝Vt
一
材料与方法：全组62例病人，男性24例，女性38例，年龄2M2岁，病史2－26年。
以风湿性心脏病为主，共56例；二尖瓣退行性变3例：感染性心内膜炎伴主动脉瓣、二
尖瓣病变各1例；先天性主动脉瓣畸形、重度主动脉溶狭窄伴外露性钙化1例。房颤心律
33例，左心房血栓10例，们瘫4例。术前心功能mWn）m级27例，w级35例。
在体外循环下行瓣膜置换手术，共植入新型人造心脏瓣膜 74只，其中 AVRll例，
MTh 39例，DTh 12例。同朋手术有：先天性缺损修补术 3例，Cox迷宫Ill型手术 4例，
左室减容术oL叮加二尖勇成形术po）l例，巨大左心房折叠术14例，左房血栓清除术
！0例，三尖泌成形术厂w怔5例．术后均接受WNn抗凝治疗，并将病人随机分为常
规抗凝强度组（INRI．63Af．30）和低抗凝强度组（INR．3oil．63）。
结果：全组62例，无手术死亡；全部获得定期随访，随访】4－72个月，总随访1920病
人．月，平均 31个月，62例均长期存活；手术 1年后心功能均从术前的Ill—IV级转为 1级，
其中35例术后半年转为1级，可不同程度的体力劳动，生活质量良好；未发生瓣膜结构
衰坏、人造瓣膜心内膜炎等并发症。术后3—8个月均作有关溶血化验，AVR、MVR、DVR
三组病例LDH都偏高，但血红蛋白、血小板计数和总胆红素均正常，在临床上未引起明
显的溶血和溶血性贫血。接受不同抗凝强度治疗的两组病人，均未发生血栓形成和血栓栓
塞并发症，但低抗凝强度组病人无抗凝出血，而常规抗凝强度组有3例小的出血事件。
11例 AVR分别在
The new type of cardiac valve prosthesis is a low profile, bileaflet mechanical prosthesis with three flow orifices. Differing from other mechanical prosthetic valves, such as St. Jude and CarboMedics valve prostheses, coated with pyrolytic carbon, this new valve prosthesis is constructed entirely with pyrolytic carbon. In vitro studies have consistently demonstrated theoretical safety and superior hemodynamic performance. In vivo study was performed in accordance with the requirements recommended by the ISO 5840-96(E) and GB 12279-90 for testing of prosthetic valves, so as to evaluate the durability, hemodynamic performance, and biocompatibility of the prosthesis.
1. Animal test
Materials and Methods: Fifteen sheep weighted about 50kg underwent mitral valve replacement with 21mm new cardiac valve prostheses under endotracheal anesthesia. Standard methods of cardiopulmonary bypass were utilized. Heparin was used in 3
months since operation. Open cardiac catheterization was performed in six animals
after mitral valve replacement. Left atrial pressure (PLA) and left ventricular pressure (PLv) were measured simultaneously by dual-catheter technique. Cardiac output (CO) was determined by thermodilution technique.
Animals were put to death at 1,12 weeks and in 30 months postoperatively by barbiturate overdose following systemic heparinization. The heart, lungs and peripheral organs including the liver, spleen and kidney were excised and examined grossly to determine if thromboembolic phenomenon occurred. The hearts were examined to observe the new endocardium on the left atrial side and the left ventricular side of the valve. Photographs of atrial and ventricular view of the prosthesis were performed. The new endocardium was subjected to electron microscopic examination. Doppler echocardiography was performed in two sheep 30 months after implantation to measure CO and transvalvular gradients and to determine if thrombosis or paravalvular leakage occurred. The second open cardiac catheterization was performed to determinate the PLA. PLV and so on. CO was measured by thermodilution technique. The hemodynamic performance of the new cardiac prosthesis was evaluated by means of dobutamine stress catheterization technique. Dobutamine was administrated at the rate of 5ug 'kg'1 fmin~1 with the dose increased every 15 minutes. PLA, PLV and CO were measured under different dobutamine doses stress, respectively. Results: 5 sheep died within 24hr after operation, 5 sheep died during 24-48hr, 5 sheep survived. 5 of the 10 deaths resulted from the anulus tore. There was no evidence of embolic phenomenon, nor were there any mechanical valve failures. The transvalvular gradients were 5.2 + 1. 7mmHg during operation, and 6.1?.3mmHg 30 months after implantation respectively. There was a minimal increase in transvalvular gradient as CO
7
increased under different dobutamine doses stress. Transvalvular gradients were 6.8 + 0. 4mmHg measured by echocardiography, similar to the invasive gradients. 2. Clinical trial
Materials and Methods: Between January, 1996 and January, 2002,62 patients underwent valve replacement with the new type of prosthetic valves. Of the 62 patients, 24 were male and 38 female. The subjects ranged in age 20?2 years. The medical history ranged 2~26 years. Rheumatic valvular disease was the predominant lesion in 56 patients, mitral valve prolapse in 3 patients, infective endocarditis associated with MI or AI respectively in 2, Congenital valvular disease in 1 patient. Of these patients, 33 were associated with atrial fibrillation, 10 with left atrial thrombus, and 4 with hemiplegia. Preoperative functional status was 27 in class III(NYHA) and 35 in class IV.
The surgical technique was similar in each case, standard cardiopulmonary bypass techniques were utilized. Of the 62 patients, 11 had AYR, 39 had MVR, and 12 had DVR. Associated procedures were performed, these included repair of congenital defect in 3 patients, the Cox Maz III procedure for treatment of atrial fibrillation i
一．动物植入研究
材料与方法：健康羊15只，气管插管、全身麻醉，颈内静脉插Swan-Ganz导管。采用标准的体外循环方法行二尖瓣置换手术，植入21mm新型人造瓣。术后肝素抗凝3个月。选
Pi以d
一
择与人造瓣匹配较好的6只羊，术中在体外循环结柬后，直视下用双导管法直接测定左房
压（Pod、左室压OLV），计算跨瓣压差；同时用热稀释法测定该时的心排量（CO）等血流动力
学参数。
长期存活的羊分批于术后1周、12周、30个月处死。所有动物都作尸检，检查人造
瓣膜有无坏损，房、室面人造瓣膜上有无血栓形成，解剖心、肺、肝、脾、肾、大脑等脏
器有无栓塞现象。2只羊在术后30个月行心脏超声检查，观察人造瓣膜在体内的状况，
有无瓣周漏及血栓形成等，并测定羊的心排量和跨瓣压差等。再次全麻、开胸，直视下用
双导管法直接测定左房压p、左室压oLV），得出跨瓣压差，同时测定该时的心排量（C）
等（方法和仪器同前）。然后用多巴酚丁胺负荷试验模拟动物的运动状况，在模拟运动状
况 F测定瓣膜的血流动力学参数。多巴酚厂胺剂量 stwin—I0twin～
20uglkg／ffiin，每隔 15分钟增加剂量，分别测定不同剂量多巴酚丁胺导致血压、心率、心
排量等变化下的P。、P。、等参数，评价人造瓣膜在运动状况下的血流动力学性能。
结果：5只羊术后24h内死亡，5只2448h死亡，另5只长期存活，生长良好，体重增
加。手术死亡均与人造瓣膜本身无关，主要手术死亡原因是羊的二尖瓣环与人造瓣膜大小
不匹配引起瓣环撕裂、急性心衰而死亡。尸检见人造瓣无坏损，机械性能良好；心腔内无
血栓形成，肺、肝、脾、肾、脑等脏器的大体检查和病理切片均无栓塞的证据：心内膜光
滑，无人造瓣膜心内膜炎的征象。术中导管测得的跨瓣压差为5．2土1．7mmHg，术后30个
月导管测得静息下的跨溶压差为6．l土0．3mlnHg。模拟运动状况下，随多巴酚丁胺剂量的
增大，心排量（CO）明显增加，而跨瓣压差随CO的明显增加仅轻度增大。心超测定的跨瓣
压差为 6．8土0．4mlnHg，与用导管法直接测得的跨瓣压差非常接近。实验表明该瓣膜的跨
瓣压差较小，血流动力学性能良好。
二．屹床桓入扭究
2
P｝Vt
一
材料与方法：全组62例病人，男性24例，女性38例，年龄2M2岁，病史2－26年。
以风湿性心脏病为主，共56例；二尖瓣退行性变3例：感染性心内膜炎伴主动脉瓣、二
尖瓣病变各1例；先天性主动脉瓣畸形、重度主动脉溶狭窄伴外露性钙化1例。房颤心律
33例，左心房血栓10例，们瘫4例。术前心功能mWn）m级27例，w级35例。
在体外循环下行瓣膜置换手术，共植入新型人造心脏瓣膜 74只，其中 AVRll例，
MTh 39例，DTh 12例。同朋手术有：先天性缺损修补术 3例，Cox迷宫Ill型手术 4例，
左室减容术oL叮加二尖勇成形术po）l例，巨大左心房折叠术14例，左房血栓清除术
！0例，三尖泌成形术厂w怔5例．术后均接受WNn抗凝治疗，并将病人随机分为常
规抗凝强度组（INRI．63Af．30）和低抗凝强度组（INR．3oil．63）。
结果：全组62例，无手术死亡；全部获得定期随访，随访】4－72个月，总随访1920病
人．月，平均 31个月，62例均长期存活；手术 1年后心功能均从术前的Ill—IV级转为 1级，
其中35例术后半年转为1级，可不同程度的体力劳动，生活质量良好；未发生瓣膜结构
衰坏、人造瓣膜心内膜炎等并发症。术后3—8个月均作有关溶血化验，AVR、MVR、DVR
三组病例LDH都偏高，但血红蛋白、血小板计数和总胆红素均正常，在临床上未引起明
显的溶血和溶血性贫血。接受不同抗凝强度治疗的两组病人，均未发生血栓形成和血栓栓
塞并发症，但低抗凝强度组病人无抗凝出血，而常规抗凝强度组有3例小的出血事件。
11例 AVR分别在
The new type of cardiac valve prosthesis is a low profile, bileaflet mechanical prosthesis with three flow orifices. Differing from other mechanical prosthetic valves, such as St. Jude and CarboMedics valve prostheses, coated with pyrolytic carbon, this new valve prosthesis is constructed entirely with pyrolytic carbon. In vitro studies have consistently demonstrated theoretical safety and superior hemodynamic performance. In vivo study was performed in accordance with the requirements recommended by the ISO 5840-96(E) and GB 12279-90 for testing of prosthetic valves, so as to evaluate the durability, hemodynamic performance, and biocompatibility of the prosthesis.
1. Animal test
Materials and Methods: Fifteen sheep weighted about 50kg underwent mitral valve replacement with 21mm new cardiac valve prostheses under endotracheal anesthesia. Standard methods of cardiopulmonary bypass were utilized. Heparin was used in 3
months since operation. Open cardiac catheterization was performed in six animals
after mitral valve replacement. Left atrial pressure (PLA) and left ventricular pressure (PLv) were measured simultaneously by dual-catheter technique. Cardiac output (CO) was determined by thermodilution technique.
Animals were put to death at 1,12 weeks and in 30 months postoperatively by barbiturate overdose following systemic heparinization. The heart, lungs and peripheral organs including the liver, spleen and kidney were excised and examined grossly to determine if thromboembolic phenomenon occurred. The hearts were examined to observe the new endocardium on the left atrial side and the left ventricular side of the valve. Photographs of atrial and ventricular view of the prosthesis were performed. The new endocardium was subjected to electron microscopic examination. Doppler echocardiography was performed in two sheep 30 months after implantation to measure CO and transvalvular gradients and to determine if thrombosis or paravalvular leakage occurred. The second open cardiac catheterization was performed to determinate the PLA. PLV and so on. CO was measured by thermodilution technique. The hemodynamic performance of the new cardiac prosthesis was evaluated by means of dobutamine stress catheterization technique. Dobutamine was administrated at the rate of 5ug 'kg'1 fmin~1 with the dose increased every 15 minutes. PLA, PLV and CO were measured under different dobutamine doses stress, respectively. Results: 5 sheep died within 24hr after operation, 5 sheep died during 24-48hr, 5 sheep survived. 5 of the 10 deaths resulted from the anulus tore. There was no evidence of embolic phenomenon, nor were there any mechanical valve failures. The transvalvular gradients were 5.2 + 1. 7mmHg during operation, and 6.1?.3mmHg 30 months after implantation respectively. There was a minimal increase in transvalvular gradient as CO
7
increased under different dobutamine doses stress. Transvalvular gradients were 6.8 + 0. 4mmHg measured by echocardiography, similar to the invasive gradients. 2. Clinical trial
Materials and Methods: Between January, 1996 and January, 2002,62 patients underwent valve replacement with the new type of prosthetic valves. Of the 62 patients, 24 were male and 38 female. The subjects ranged in age 20?2 years. The medical history ranged 2~26 years. Rheumatic valvular disease was the predominant lesion in 56 patients, mitral valve prolapse in 3 patients, infective endocarditis associated with MI or AI respectively in 2, Congenital valvular disease in 1 patient. Of these patients, 33 were associated with atrial fibrillation, 10 with left atrial thrombus, and 4 with hemiplegia. Preoperative functional status was 27 in class III(NYHA) and 35 in class IV.
The surgical technique was similar in each case, standard cardiopulmonary bypass techniques were utilized. Of the 62 patients, 11 had AYR, 39 had MVR, and 12 had DVR. Associated procedures were performed, these included repair of congenital defect in 3 patients, the Cox Maz III procedure for treatment of atrial fibrillation i
引文
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16．田子朴，罗传兴，黄旭中，等。双叶机械瓣的研制和临床应用报告．中华胸心血管外科杂志，1992，8(1)：1
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19.International Standard:Cardiovascular Implants-Cardiac Valve Prostheses.ISO5840,3nd ed,1996
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28． Palma A, Moffman DM, Nanna M, et al. Transesophageal echocardiography for the evaluation of mitral valve prostheses in the weanling sheep. ASAIO Trans 1991;37(3) :M240-1
29． Tatineni S, Barner HB, Pearson AC, et al. Rest and exercise evaluation of St. Jude Medical and Medtronic Hall Prostheses. Circulation 1989,80(suppl I): 16-23
30． Horstkotte D, Haerten K, Korfker R, et al. Haemodynamic findings at rest and during exercise after implantation of different aortic valve prostheses. Z Kardiol 1983,72:429-37
31． Reisner SA. Meltzer RS. Normal values of prosthetic valve Doppler echocardiography parameters: a review. J Am Soc Echocardiogr 1988,1:201-10
32． Panidis JP, Ross J, Mintz GS. Normal and abnormal prosthetic valve function as assessed by Dopple echocardiography. J Am coll Cardiol 1986,8:317-26
33． Berthe C, Pierard LA, Hiernaux M, et al. Predicting the extent and location of coronary artery disease in acute myocardiol infarction by echocardiography during dobutamine infusion. Am J Cardiol 1986,58:1167-72
34． Mertes H, Sawaria SG, Ryan T, et al. Symptoms adverse effects, and complications associated with doubtamine stress echocardiography. Circulation 1993,88:15-9
35． Currier PJ, Seward JB, Reeder GS, et al. Continuous-wave Doppler echocardiographic assessment of severity of calcific aortic stenosis: A simultaneous Doppler-Catheter correlative study in 100 adult patients. Circulation 1985,71:1162-1169
36． Holen J, Aaslid R, Landmark K, et al. Determination of pressure gradient in mitral stenosis with a non-invasive ultrasound Doppler technique. Acta Med Scand 1976,199:455
37． Hatle L, Brubakk A, Tromsdal A, et al. Noninvasive assessment of pressure drop in mitral stenosis by Doppler ultrasound. Br Heart J 1978,40:131
38． Chambers J, Cross J, Deverall P, et al. Echocardiographic description of the CarboMedics Bileaflet prosthetic heart valve. J Am Coll Cardiol 1993,21:398-405
39． Nishimura RA, Tajik AJ. Determination of left-sided pressure gradients by utilizing Doppler aortic and mitral regurgitant signals: Validation by simultaneous dual catheter and Doppler studies. J Am Coll Cardiol 1988,11:317-321
40． Rothbart RM, Smucker ML, Gibson RS. Overestimation by Doppler echocardiography off pressure gradients across starr-Edwards prosthetic valve in aortic position. Am J Cardiol 1988,61:475-476
41． De Paulis R, Sommariva L, Russo F, et al .Doppler echocardio-graphy evaluation of the CarboMedics valve in patients with small aortic anulns
and valve prosthesis-body surface area mismatch. J Thorac Cardiovasc Surg 1994,108:57-62
42． Iaske A, Jenni R, Maloigne M, et al. Pressure gradients across bileaflet aortic valves by measurement and echocardiography. Ann Thorac Surg 1996,61:48-57
43． Burstow DJ, Nishimura RA, Bailery KR, et al. Continuous wave Dopple echocardiographic measurement of prosthetic valve gradients: A simultaneous Doppler-catheter correlative study. Circulation 1989,80:504-514
44． Kuntze CEE, Blackstone EH, Ebels T. Thromboembolism and mechanical heart valves: a randomized study revisited. Ann thorac Surg, 1998,66(1) : 101-107
45． Aoyagi S, Orgoji A, Nishi Y, et al. Long-term results of valve replacement with the St Jude Medical Valve. J thorac Cardiovasc Surg, 1994,108(6) : 1021-1029
46． Debetaz LF, Ruchat P, Hurni M, et al. St. Jude Medical valve prosthesis: an analysis of long-term outcome and prognostic factors. J Thorac Cardiovasc Surg,1997,113(1) :134-148
47． Bull B, Fuchs JCA, Braunwald NS. Mechanism of formation of tissue layers on the fabric lattice covering intravascular prosthetic devices. Surg 1969,65:640
48． Berger K, Sauvage LR, Wood SJ, et al. Sewing ring healing of cardiac valve prostheses. Surg 1967,61:102
49． Braunwald NS, Bonchek LI. Prevention of thrombus formation on rigid prosthetic heart valves by the ingrowth of autogenous tissue. J Thorac Cardiovasc Surg, 1967,54:630
50． Edmunds LH Jr, Clark RE, Cohn LH, et al. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg, 1988,46:257-259
51． Arom KV, Nicoloff DM, Kersten TE, et al. Ten years' experience with the St. Jude Medical valve prosthesis. Ann Thorac Surg,1989,47:831-7
52． Bodnar E, Haberman S, Wain WH, et al. Comparative method for actuarial analysis of cardiac valve replacements. Br Heart J,1979,42:541-552
53． Nicoloff DM, Emery RW, Arom KV, et al. Clinical and hemodynamic results with the St. Jude Medical cardiac valve prosthesis: a Three-year experience. J Thorac Cardiovasc Surg, 1981,82:674-683
54． Chambers J, Ely JL. Early postoperative echocardiographic hemodynamic performance of the On-X prosthetic heart valve: a multicenter study. J Heart Valve Dis, 1998,7(5) :569-73
55． DeWall RA, Qasim N, Carr L, et al. Evolution of mechanical heart valves. Ann Thorac Surg, 2000,69:1612-1621
56． Autschbach R, Walther T, Falk V, et al. Prospective randomized comparison of different mechanical aortic valves. Circulation, 2000,102 (suppl III): III-1-III-4
57． Grunkemeier GL, Li H, Naftel DC, et al. Long-term performance of heart valve prostheses. Curr Proble Cardiol,2000,25:75-154
58.Laske A, Jenni R, Maloigne M, et al. Pressure gradients across bileaflet aortic valves by direct measurement and echocardiography. Ann Thorac Surg, 1996,61:48-57
59.Chu Yinping, Chen Rukun, Fan Yubo, et al. Hydrodynamics of a newly China-made Jiuling Bileaflet Heart Valve Prosthesis. Chinese J BioMed. Eng, 2000,9(4): 168～179
60.Dong Aiqiang, Chen Rukun, Xu Shiwei, et al. Experimental study of China-made JiuLing Solid Pyrolytic Carbon Bileaflet Prosthetic Heart Valve in Sheep. Chinese J Biomed Eng, 2000,9(1):18～25
61．董爱强，陈如坤，张昌铭，等．国产全热解碳双叶瓣的动物实验．浙江大学学报医学版)，2000，29(4)：162～164
62．陈如坤，董爱强，徐世伟，等．国产久灵全热解碳双叶型人造心脏瓣膜的临床研究．中华医学杂志，2000，80(9)：687～688．
63.Chen Rukun, Dong Aiqiang, Xu Shiwei, et al. Initial experience with China-made Jiuling solid pyrolytic carbon bileaflet prosthetic heart valve:hemodynamic performance, surgical results, biocompatibility and follow-up. Chinese Medical Journal (网络版),2001,1
64.Chambers J, Ely .JL. Early postoperative echocardiographic hemodynamic performance of the On-X prosthetic heart valve: a multicenter study. J Heart Valve Dis,1998,7(5):569-73
65.Aoyagi S, Yasunaga H, Sato T, et al. Doppler echocardiographic evaluation of St. Jude Medical valve. Artif Organs Today, 1995,5:49-57
66.Stein PD, Alpert Js, Bussey HI, et al. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest,2001,119:220～227.
67． Horstkotte D, Schulte HD, Bircks, et al. Lower intensity anticoagulation therapy results in lower complication rates with the St. Jude Medical prosthesis. J Thorac Cadiovase Surg 1994; 107:1136-1145
68． Fiore AC, Barner HB, Swartz MT, et al. Mitral valve replacement: randomized trial of St.Jude and Medtronic Hall prostheses. Ann Thorac Surg 1998;66:707-713
69． Vogt S, Hoffmann A, Roth J, et al. Heart valve replacement with the Bjork-Shiley and StJude Medical prostheses: a randomized comparison in 178 patients. Eur Heart J 1990;11:585-591
70． Acar J, Iung B, Boissel JP, et al. AREVA: Multicenter randomized comparison of low-dose versus standard dose anticoagulation in patients with mechanical prosthetic heart valves. Circulation, 1996;94:2107-2112
71． Horstkotte D, Schulte H, Bircks W, et al. Unexpected findings concerning thromboembolic complications and anti-coagulation after complete 10 year follow up of patients with St.Jude Medical Prostheses. J Heart Valve Dis, 1993 ;2:291-301
72． Stein PD, Grandison D, Hua TA, et al. Therapeutic level of oral anticoagulation with warfarin in patients with mechanical prosthetic heart valves: review of literature and recommendations based on international normalized ratio. Postgrad Med J, 1994;70(suppl 1) :S72-S83
73． Horstkotte D, Scharf RE, Schultheiss HP. Intracardiac thrombosis: patient-related and device-related factors. J Heart Valve Dis, 1995;4:114-120
74． Butchart EG. Lewis PA, Grunkemeier GL, et al. Low risk of thrombosis and serious embolic events despite low-intensity anticoagulation. Circulation, 1988;78(suppl I):166-177
75． Gossinger H, Neissner H, Grubeck B, et al. Thromboembolism in patients with prosthetic heart valves: an adequately controlled intense anticoagulant therapy and its influence on the occurrence of thromboembolism in relation to valve type. Thorac Cardiovasc Surg, 1986;34:283-286
76． Van der Meer FJM, Rosendaal FR, Vandenbroucke JP, et al. Bleeding complications in oral anticoagulant therapy: an analysis of risk factors. Arch Intern Med, 1993;153:1557-1562
77． Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med, 1994; 120:897-902
78． Cappelleri JC, Fiore L, Brophy M, et al. Efficacy safety of combined anticoagulant and antiplatelet therapy versus anticoagulant monotherapy after mechanical heart-valve replacement: a meta-analysis. Am Heart J, 1995;130:547-552
79． Altman R, Rouvier J, Gurfinkel E, et al. Comparison of two levels of anticoagulant therapy in patients with substitute heart valves. J Thorac Cardiovasc Surg, 1991;101:427-431
80． Altman R, Rouvier L, Gurfinkel E, et al. Comparison of high-dose and low-dose aspirin in patients with mechanical heart valve replacement treated with oral anticoagulant. Circulation, 1996;94:2113-2116
81． Albertal J, Sutton M, Pereyra D, et al. Experience with moderate intensity anticoagulation and aspirin alter mechanical valve replacement: a retrospective, non-randomized study. J Heart Valve Dis, 1993;2:302-307
82． Louagie YA, Jamart J, Eucher P, et al. Mitral valve Carpentier-Edwards bioprosthetic replacement, thromboembolism, and anticoagulants. Ann Thorac Surg, 1993;56:931-937
83． Meschengieser SS, Carlos GF, Santarelli MT, et Low-intensity oral anticoagulation plus low-dose aspirin versus high-intensity oral anticoagulation alone :a randomized trial in patients with mechanical prosthetic heart valves. J Thorac Cardiovasc Surg 1997;113:910-916
84． Rodler SM, Moritz A, Schreiner W, et al. Five-year follow-up after heart valve replacement with the CarboMedics bileaflet prostgesis. J Thorac Cardiovasc Surg,1997,63:1018-25
85． Weinstein L: Infective Endocarditis, The Heart: A Text of Cardiovascular Medicine, ed 1, Braunwald E, ed, Philadelphia, 1980, W. B. Saunders Company, p1178
86． Lim KH, Caputo M, Ascione R, et al. Prospective randomized comparison of CarboMedics and St Jude Medical bileafletmechanical heart valve prostheses: an interim report. J Thorac Cardiovasc Surg, 2002 ,123(1) :21-32
87． Mylonakis E, Calderwood SB. Infective endocarditis in adults. N Engl J Med. 2001,345(18) :1318-30．
88． Grunenfelder J, Akins CW, Hilgenberg AD, et al. Long-term results and determinants of mortality after surgery for native and prosthetic valve endocarditis. J Heart Valve Dis,2001,10(6) :694-70
2．陈如坤．人造瓣膜置换术的抗凝血处理(附653例报告)．中华外科杂志，1985，27(1)：13
3.Harkcn DE, Soroff HS, Taylor WJ, et al. Partial and complete prostheses in aortic insufficiency. J Thorac Cardiovase. Surg 1960,40:744-762
4.Starr A, Edwards ML. Mitral replacement: a clinical experience with the ball valve prosthesis. Ann Surg 1961,154:726-40
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6.Lazaros GA, Dounis GB, Panou FC, et al. Thirty one-year durability of a Starr-Edwards aortic prosthesis. J cardiovasc Surg, 1998, 39(5):659～662
7.Miller DC, Oyer PE, Stinson EB, et al. Ten to fifteen years reassessment of the performance characteristics of the Starr-Edwards Model 6120 mitral valve prosthesis. J thorac Cardiovasc Surg, 1983,85(1): 1～20
8.Akins CW. Long-term results with the Medtronic-Hall valvular prosthesis. Ann Thorac Surg, 1996,61(3):806～823
9.Antunes M J, Wessels A, Sadowski RG, et al. Medtronic-Hall valve replacement in a third-world population group: a review of the performance of 1000 prostheses. J thorac Cardiovasc Surg, 1988, 95(6):980～993
10.Obadia JF, Martelloni YA, Bastien OH, et al. Long-term follow-up of small (size 20 and 21)Medtronic-Hall aortic valve prostheses. Ann thorac Surg, 1997, 64(2):421～425
11.Wu ZJ, Hwang NH. Ventricular pressure slope and bileaflet mechanical heart valve closure. ASAIO J, 1995, 41(3): M-7d3～M-767
12.Emery RW, Nicoloff DM. St. Jude Medical cardiac valve prosthesis in vitro studies. J Thorac Cardiovasc Surg 1979;78(2):269～276
13.Jamieson WRE, Miyagishima RT, Tyers GFO, et al. Bileaflet mechanical prostheses in mitral and multiple valve replacement surgery: influence of anticoagulant management on performance. Circulation, 1997,96(Suppl Ⅱ):Ⅱ-134～Ⅱ-140
14.Emery RW, Palmquist WE, Metter E, et al. A new cardiac prosthesis: in vitro results. Trans Am Soc Artif Intern Organs, 1978,24:550～556
15.Bernal JM, Rabasa JM, Outierrez-Garcia F, et al. The CarboMedics valve:experience with 1,049 implants. Ann Thorac Surg, 1998,65(1):137～143
16．田子朴，罗传兴，黄旭中，等。双叶机械瓣的研制和临床应用报告．中华胸心血管外科杂志，1992，8(1)：1
17．康振黄，陈君楷，袁支润，等．一种新型人工机械心瓣—双叶翼型瓣的开发研究．中国生物医学工程学报，1993，12(3)：168～177
18．国家技术监督局．人工心脏瓣膜通用技术条件．中华人民共和国国家标准 GB 12279-90)．北京：中国标准出版社，1991
19.International Standard:Cardiovascular Implants-Cardiac Valve Prostheses.ISO5840,3nd ed,1996
20． Emery RW, Mettler E, Nicoloff DM. A new cardiac prosthesis: The St. Jude Medical valve in vivo resutls. Circulation 1979,60(Suppl. I):48-54
21． Ryder JK, Cao H. Structural integrity assessment of heart valve prosthesis: a damage tolerance analysis of the CarboMedics prosthetic valve. J Heart valve Dis, 1996,S(suppl I):86-96
22． De Luca L, Vitale N, Giannolo B, et al. Mid-term follow-up after valve replacement with CarboMedics bileaflet prostheses. J Thorac Cardiovasc Surg, 1993,106(5) :1158-1165
23． Izzat, Birdi, Wilde, et al. Comparison of hemodynamic performances of St. Jude Medical and CarboMedics 21 mm aortic prostheses by means of Dobutamine stress of echocardiography. J Thorac Cardiovasc Surg 1996;111(2) :408-15
24． Ihlen H, Molstad P, Simonsen S, et al. Hemodynamic evaluation of the CarboMedics prosthetic heart valve in aortic positison: Comparion of noninvasive and invasive techniques. Am Heart J 1992;123(1) :151-159
25． 陈如坤，纪荣明，羊心的二尖瓣装置，中华心血管病杂志. 1992, 20 (6) : 373
26． 陈如坤. The animal model of acute mitral regurgitation. Chinese Journal of Biomedical Engineering (English Edition), 1992,1(1) :1-6
27． 陈如坤，赵月华，张琦.An Experimental study of simple or complex acute trauma of mitral chorde tendinae in goat by color doppler imaging. Cardiology WFUMB Copenhagen 1991,603
28． Palma A, Moffman DM, Nanna M, et al. Transesophageal echocardiography for the evaluation of mitral valve prostheses in the weanling sheep. ASAIO Trans 1991;37(3) :M240-1
29． Tatineni S, Barner HB, Pearson AC, et al. Rest and exercise evaluation of St. Jude Medical and Medtronic Hall Prostheses. Circulation 1989,80(suppl I): 16-23
30． Horstkotte D, Haerten K, Korfker R, et al. Haemodynamic findings at rest and during exercise after implantation of different aortic valve prostheses. Z Kardiol 1983,72:429-37
31． Reisner SA. Meltzer RS. Normal values of prosthetic valve Doppler echocardiography parameters: a review. J Am Soc Echocardiogr 1988,1:201-10
32． Panidis JP, Ross J, Mintz GS. Normal and abnormal prosthetic valve function as assessed by Dopple echocardiography. J Am coll Cardiol 1986,8:317-26
33． Berthe C, Pierard LA, Hiernaux M, et al. Predicting the extent and location of coronary artery disease in acute myocardiol infarction by echocardiography during dobutamine infusion. Am J Cardiol 1986,58:1167-72
34． Mertes H, Sawaria SG, Ryan T, et al. Symptoms adverse effects, and complications associated with doubtamine stress echocardiography. Circulation 1993,88:15-9
35． Currier PJ, Seward JB, Reeder GS, et al. Continuous-wave Doppler echocardiographic assessment of severity of calcific aortic stenosis: A simultaneous Doppler-Catheter correlative study in 100 adult patients. Circulation 1985,71:1162-1169
36． Holen J, Aaslid R, Landmark K, et al. Determination of pressure gradient in mitral stenosis with a non-invasive ultrasound Doppler technique. Acta Med Scand 1976,199:455
37． Hatle L, Brubakk A, Tromsdal A, et al. Noninvasive assessment of pressure drop in mitral stenosis by Doppler ultrasound. Br Heart J 1978,40:131
38． Chambers J, Cross J, Deverall P, et al. Echocardiographic description of the CarboMedics Bileaflet prosthetic heart valve. J Am Coll Cardiol 1993,21:398-405
39． Nishimura RA, Tajik AJ. Determination of left-sided pressure gradients by utilizing Doppler aortic and mitral regurgitant signals: Validation by simultaneous dual catheter and Doppler studies. J Am Coll Cardiol 1988,11:317-321
40． Rothbart RM, Smucker ML, Gibson RS. Overestimation by Doppler echocardiography off pressure gradients across starr-Edwards prosthetic valve in aortic position. Am J Cardiol 1988,61:475-476
41． De Paulis R, Sommariva L, Russo F, et al .Doppler echocardio-graphy evaluation of the CarboMedics valve in patients with small aortic anulns
and valve prosthesis-body surface area mismatch. J Thorac Cardiovasc Surg 1994,108:57-62
42． Iaske A, Jenni R, Maloigne M, et al. Pressure gradients across bileaflet aortic valves by measurement and echocardiography. Ann Thorac Surg 1996,61:48-57
43． Burstow DJ, Nishimura RA, Bailery KR, et al. Continuous wave Dopple echocardiographic measurement of prosthetic valve gradients: A simultaneous Doppler-catheter correlative study. Circulation 1989,80:504-514
44． Kuntze CEE, Blackstone EH, Ebels T. Thromboembolism and mechanical heart valves: a randomized study revisited. Ann thorac Surg, 1998,66(1) : 101-107
45． Aoyagi S, Orgoji A, Nishi Y, et al. Long-term results of valve replacement with the St Jude Medical Valve. J thorac Cardiovasc Surg, 1994,108(6) : 1021-1029
46． Debetaz LF, Ruchat P, Hurni M, et al. St. Jude Medical valve prosthesis: an analysis of long-term outcome and prognostic factors. J Thorac Cardiovasc Surg,1997,113(1) :134-148
47． Bull B, Fuchs JCA, Braunwald NS. Mechanism of formation of tissue layers on the fabric lattice covering intravascular prosthetic devices. Surg 1969,65:640
48． Berger K, Sauvage LR, Wood SJ, et al. Sewing ring healing of cardiac valve prostheses. Surg 1967,61:102
49． Braunwald NS, Bonchek LI. Prevention of thrombus formation on rigid prosthetic heart valves by the ingrowth of autogenous tissue. J Thorac Cardiovasc Surg, 1967,54:630
50． Edmunds LH Jr, Clark RE, Cohn LH, et al. Guidelines for reporting morbidity and mortality after cardiac valvular operations. Ann Thorac Surg, 1988,46:257-259
51． Arom KV, Nicoloff DM, Kersten TE, et al. Ten years' experience with the St. Jude Medical valve prosthesis. Ann Thorac Surg,1989,47:831-7
52． Bodnar E, Haberman S, Wain WH, et al. Comparative method for actuarial analysis of cardiac valve replacements. Br Heart J,1979,42:541-552
53． Nicoloff DM, Emery RW, Arom KV, et al. Clinical and hemodynamic results with the St. Jude Medical cardiac valve prosthesis: a Three-year experience. J Thorac Cardiovasc Surg, 1981,82:674-683
54． Chambers J, Ely JL. Early postoperative echocardiographic hemodynamic performance of the On-X prosthetic heart valve: a multicenter study. J Heart Valve Dis, 1998,7(5) :569-73
55． DeWall RA, Qasim N, Carr L, et al. Evolution of mechanical heart valves. Ann Thorac Surg, 2000,69:1612-1621
56． Autschbach R, Walther T, Falk V, et al. Prospective randomized comparison of different mechanical aortic valves. Circulation, 2000,102 (suppl III): III-1-III-4
57． Grunkemeier GL, Li H, Naftel DC, et al. Long-term performance of heart valve prostheses. Curr Proble Cardiol,2000,25:75-154
58.Laske A, Jenni R, Maloigne M, et al. Pressure gradients across bileaflet aortic valves by direct measurement and echocardiography. Ann Thorac Surg, 1996,61:48-57
59.Chu Yinping, Chen Rukun, Fan Yubo, et al. Hydrodynamics of a newly China-made Jiuling Bileaflet Heart Valve Prosthesis. Chinese J BioMed. Eng, 2000,9(4): 168～179
60.Dong Aiqiang, Chen Rukun, Xu Shiwei, et al. Experimental study of China-made JiuLing Solid Pyrolytic Carbon Bileaflet Prosthetic Heart Valve in Sheep. Chinese J Biomed Eng, 2000,9(1):18～25
61．董爱强，陈如坤，张昌铭，等．国产全热解碳双叶瓣的动物实验．浙江大学学报医学版)，2000，29(4)：162～164
62．陈如坤，董爱强，徐世伟，等．国产久灵全热解碳双叶型人造心脏瓣膜的临床研究．中华医学杂志，2000，80(9)：687～688．
63.Chen Rukun, Dong Aiqiang, Xu Shiwei, et al. Initial experience with China-made Jiuling solid pyrolytic carbon bileaflet prosthetic heart valve:hemodynamic performance, surgical results, biocompatibility and follow-up. Chinese Medical Journal (网络版),2001,1
64.Chambers J, Ely .JL. Early postoperative echocardiographic hemodynamic performance of the On-X prosthetic heart valve: a multicenter study. J Heart Valve Dis,1998,7(5):569-73
65.Aoyagi S, Yasunaga H, Sato T, et al. Doppler echocardiographic evaluation of St. Jude Medical valve. Artif Organs Today, 1995,5:49-57
66.Stein PD, Alpert Js, Bussey HI, et al. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest,2001,119:220～227.
67． Horstkotte D, Schulte HD, Bircks, et al. Lower intensity anticoagulation therapy results in lower complication rates with the St. Jude Medical prosthesis. J Thorac Cadiovase Surg 1994; 107:1136-1145
68． Fiore AC, Barner HB, Swartz MT, et al. Mitral valve replacement: randomized trial of St.Jude and Medtronic Hall prostheses. Ann Thorac Surg 1998;66:707-713
69． Vogt S, Hoffmann A, Roth J, et al. Heart valve replacement with the Bjork-Shiley and StJude Medical prostheses: a randomized comparison in 178 patients. Eur Heart J 1990;11:585-591
70． Acar J, Iung B, Boissel JP, et al. AREVA: Multicenter randomized comparison of low-dose versus standard dose anticoagulation in patients with mechanical prosthetic heart valves. Circulation, 1996;94:2107-2112
71． Horstkotte D, Schulte H, Bircks W, et al. Unexpected findings concerning thromboembolic complications and anti-coagulation after complete 10 year follow up of patients with St.Jude Medical Prostheses. J Heart Valve Dis, 1993 ;2:291-301
72． Stein PD, Grandison D, Hua TA, et al. Therapeutic level of oral anticoagulation with warfarin in patients with mechanical prosthetic heart valves: review of literature and recommendations based on international normalized ratio. Postgrad Med J, 1994;70(suppl 1) :S72-S83
73． Horstkotte D, Scharf RE, Schultheiss HP. Intracardiac thrombosis: patient-related and device-related factors. J Heart Valve Dis, 1995;4:114-120
74． Butchart EG. Lewis PA, Grunkemeier GL, et al. Low risk of thrombosis and serious embolic events despite low-intensity anticoagulation. Circulation, 1988;78(suppl I):166-177
75． Gossinger H, Neissner H, Grubeck B, et al. Thromboembolism in patients with prosthetic heart valves: an adequately controlled intense anticoagulant therapy and its influence on the occurrence of thromboembolism in relation to valve type. Thorac Cardiovasc Surg, 1986;34:283-286
76． Van der Meer FJM, Rosendaal FR, Vandenbroucke JP, et al. Bleeding complications in oral anticoagulant therapy: an analysis of risk factors. Arch Intern Med, 1993;153:1557-1562
77． Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med, 1994; 120:897-902
78． Cappelleri JC, Fiore L, Brophy M, et al. Efficacy safety of combined anticoagulant and antiplatelet therapy versus anticoagulant monotherapy after mechanical heart-valve replacement: a meta-analysis. Am Heart J, 1995;130:547-552
79． Altman R, Rouvier J, Gurfinkel E, et al. Comparison of two levels of anticoagulant therapy in patients with substitute heart valves. J Thorac Cardiovasc Surg, 1991;101:427-431
80． Altman R, Rouvier L, Gurfinkel E, et al. Comparison of high-dose and low-dose aspirin in patients with mechanical heart valve replacement treated with oral anticoagulant. Circulation, 1996;94:2113-2116
81． Albertal J, Sutton M, Pereyra D, et al. Experience with moderate intensity anticoagulation and aspirin alter mechanical valve replacement: a retrospective, non-randomized study. J Heart Valve Dis, 1993;2:302-307
82． Louagie YA, Jamart J, Eucher P, et al. Mitral valve Carpentier-Edwards bioprosthetic replacement, thromboembolism, and anticoagulants. Ann Thorac Surg, 1993;56:931-937
83． Meschengieser SS, Carlos GF, Santarelli MT, et Low-intensity oral anticoagulation plus low-dose aspirin versus high-intensity oral anticoagulation alone :a randomized trial in patients with mechanical prosthetic heart valves. J Thorac Cardiovasc Surg 1997;113:910-916
84． Rodler SM, Moritz A, Schreiner W, et al. Five-year follow-up after heart valve replacement with the CarboMedics bileaflet prostgesis. J Thorac Cardiovasc Surg,1997,63:1018-25
85． Weinstein L: Infective Endocarditis, The Heart: A Text of Cardiovascular Medicine, ed 1, Braunwald E, ed, Philadelphia, 1980, W. B. Saunders Company, p1178
86． Lim KH, Caputo M, Ascione R, et al. Prospective randomized comparison of CarboMedics and St Jude Medical bileafletmechanical heart valve prostheses: an interim report. J Thorac Cardiovasc Surg, 2002 ,123(1) :21-32
87． Mylonakis E, Calderwood SB. Infective endocarditis in adults. N Engl J Med. 2001,345(18) :1318-30．
88． Grunenfelder J, Akins CW, Hilgenberg AD, et al. Long-term results and determinants of mortality after surgery for native and prosthetic valve endocarditis. J Heart Valve Dis,2001,10(6) :694-70